Non-Hodgkin LymphomaPhase 2NCT00444912
The Effect of Rituximab on Mobilization With AMD3100 (Plerixafor) Plus G-CSF in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma (NHL) or Hodgkin Disease (HD)
A Phase 2 study testing G-CSF plus plerixafor and rituximab in people with Non-Hodgkin Lymphoma and Hodgkin Disease, run by Genzyme, a Sanofi Company at 1 site in United States.
Trial summary
Participants with non-Hodgkin lymphoma (NHL) or Hodgkin disease (HD) will be assigned to one of 2 arms based on the immunophenotype of their lymphoma. (A)Participants with CD20(-) lymphoma will undergo mobilization with granulocyte colony-stimulating factor (G-CSF) and plerixafor. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-Hodgkin Lymphoma, Hodgkin Disease
- What is being tested?
- G-CSF plus plerixafor and rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Jun 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological diagnosis of diffuse large cell lymphoma, B-cell, T-cell or anaplastic histologies; peripheral T-cell lymphoma; small non-cleaved Burkitt-like lymphoma; or Hodgkin disease. NOTE: Participants diagnosed at a facility outside of Emory University will have their diagnosis confirmed by Emory University pathologists prior to being enrolled in this study.
- Eligible for autologous transplantation.
- History of relapse of lymphoma following initial treatment with an anthracycline-containing regimen or disease that is refractory or progresses during initial therapy with an anthracycline-containing regimen.
- Immunophenotyping of the lymphoma at the time of diagnosis or relapse using flow cytometry or immunohistochemistry.
- Presence of clinically- and/or radiologically-documented, measurable, and/or evaluable disease at the time of relapse.
- Received 2 cycles of salvage chemotherapy.
Show all 15Show fewer
- Complete response (i.e., normal physical examination, lymph nodes, lymph node masses, and bone marrow) or a partial response (i.e., decrease of ≧50% in the size of lymph nodes or lymph node masses or decrease in size of liver/spleen on physical exam) to at least one cycle of a salvage chemotherapy regimen.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Absolute granulocytes count ≧1.0*10^9/l.
- Platelet count ≧75*10^9/l.
- Aspartate aminotransferase (AST) or alanine transaminase (ALT) ≦2.5 times the upper limit of normal (ULN) or ≦5 times the ULN if liver involvement with lymphoma.
- Life expectancy of at least 3 months.
- >4 weeks since last cycle of chemotherapy.
- Patient has recovered from all acute toxic effects of prior chemotherapy.
- Signed informed consent.
Who cannot join
- A second active malignancy (other than basal cell carcinoma of the skin).
- Uncontrolled central nervous system involvement by lymphoma.
- Positive/history of retroviral infection (HIV, HTLV-1).
- Active infection requiring antibiotics during planned lymphoma-related therapy.
- Previous treatment with high-dose chemotherapy or cytokine mobilization and hematopoietic progenitor cell transplantation.
- Continued evidence by morphology and flow cytometry of bone marrow involvement after at least one cycle of salvage chemotherapy.
Show all 22Show fewer
- ≥3 cycles of salvage chemotherapy following documentation of lymphoma relapse or disease progression.
- (In patients with CD20(+) lymphoma) History of severe hypersensitivity reactions to rituximab.
- Positive pregnancy test in female patients.
- Lactating female patients.
- Previously received experimental therapy within 4 weeks of enrolling in this protocol or currently enrolled in another experimental protocol during G-CSF Mobilization Phase.
- Creatinine >1.5 times the ULN.
- Bilirubin >1.5 times the ULN.
- Ejection fraction <45%.
- Diffusion capacity of the lung for carbon monoxide (DLCO) <50%.
- Patients of childbearing potential unwilling to implement adequate birth control.
- A co-morbid condition that renders the patient at high risk from treatment complications.
- Residual acute medical condition resulting from prior chemotherapy.
- Documented history of ventricular arrhythmias during the last 3 years.
- Fever (temperature >38 °C/100.4 °F).
- Actual body weight exceeds 175% of ideal body weight.
- Participants who have deterioration of their clinical status or laboratory parameters between the time of enrolment and transplant (such that they no longer meet entry criteria) may be removed from study at the discretion of the treating physician, principal investigator, or sponsor.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Cohort Study of AMD3100 in Combination With G-CSF and Rituximab Compared With AMD3100 in Combination With G-CSF Alone for Mobilization of BPCs in Patients With Relapsed or Refractory NHL or HD Prior to Autologous HPC Transplant
Participants with non-Hodgkin lymphoma (NHL) or Hodgkin disease (HD) will be assigned to one of 2 arms based on the immunophenotype of their lymphoma.
(A)Participants with CD20(-) lymphoma will undergo mobilization with granulocyte colony-stimulating factor (G-CSF) and plerixafor.
Read more
(B) Participants with CD20(+) lymphomas will undergo mobilization with rituximab, G-CSF, and plerixafor. They will receive a weekly dose of rituximab beginning 1 week prior to, and continuing until 2 weeks after, the first dose of G-CSF.
Participants in both groups will receive G-CSF twice daily for 4 days. In the evening on Day 4, a dose of plerixafor will be administered. Apheresis will be initiated the next morning. Participants will continue to receive G-CSF twice daily and to receive the evening dose of plerixafor followed by apheresis the next morning for up to a total of 4 aphereses or until ≥5*10^6 CD34+ cells/kg are collected.
Participants who are transplanted will be monitored for the time to polymorphonuclear leukocytes (PMN), platelets (PLT), and lymphocyte engraftment. Follow-up assessments will be done at 100 days, and 6 and 12 months post-transplantation.
Read the detailed description
This is a single-center, 2-arm, non-randomized, open-label study to evaluate the safety of plerixafor when used in combination with rituximab (Rituxan®) and granulocyte colony-stimulating factor (G-CSF) in patients with relapsed or refractory Hodgkin disease (HD) or non-Hodgkin lymphoma (NHL).
Participants will be assigned to one of 2 arms based on the immunophenotype of their lymphoma.
(A)Participants with CD20(-) lymphoma will undergo mobilization with G-CSF and plerixafor.
(B) Participants with CD20(+) lymphomas will undergo mobilization with rituximab, G-CSF, and plerixafor. They will receive a weekly dose of 375 mg/m2 rituximab by intravenous (iv) infusion beginning 1 week prior to, and continuing until 2 weeks after, the first dose of G-CSF.
Participants in both groups will receive 7.5 µg/kg G-CSF twice daily (morning and evening) for 4 days. In the evening (approximately 10:00 pm) on Day 4, a dose of plerixafor (240 µg/kg) will be administered. Apheresis will be initiated the next morning, approximately 10 to 11 hours after plerixafor is given. Participants will continue to receive G-CSF twice daily and to receive the evening dose of plerixafor followed by apheresis the next morning for up to a total of 4 aphereses or until ≥5*10^6 CD34+ cells/kg are collected.
Participants with an adequate number of autologous peripheral blood stem cells (PBSCs) collected by apheresis will be admitted to the study center for the administration of high-dose chemotherapy and autologous transplantation. After transplantation, the times to PMN, PLT, and lymphocyte engraftment will be measured. Participants will remain hospitalized until they achieve an absolute granulocyte count of >500/µl in the peripheral blood. Graft durability will be assessed at 100 days, and 6 and 12 months post-transplantation.
This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.
- Conditions
- Non-Hodgkin Lymphoma, Hodgkin Disease
- Being tested
- G-CSF plus plerixafor, rituximab
- Keywords
- AMD3100, stem cell mobilization, autologous transplant, Non-Hodgkin Lymphoma, Hodgkin Disease
- Medical subject headings
- Lymphoma, Non-Hodgkin, Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G-CSF plus plerixaforDrug
Also called AMD3100, Mozobil
Participants underwent mobilization with G-CSF (7.5 µg/kg twice daily) for 4 days, administered by subcutaneous (sc) injection. On the evening of Day 4, participants received a dose of plerixafor (240 µg/kg), administered by SC injection. On Day 5, participants returned to the clinic and received a morning dose of G-CSF (7.5 µg/kg) and underwent apheresis approximately 10 to 11 hours after the dose of plerixafor. Participants were to continue to receive G-CSF twice daily and to receive the evening dose of plerixafor followed by apheresis the following morning for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
G-CSF plus plerixaforDrug
Also called Mozobil, AMD3100
Participants underwent mobilization with G-CSF (7.5 µg/kg twice daily) for 4 days, administered by subcutaneous (SC) injection. On the evening of Day 4, participants received a dose of plerixafor (240 µg/kg), administered by SC injection. On Day 5, participants returned to the clinic and received a morning dose of G-CSF (7.5 µg/kg) and underwent apheresis approximately 10 to 11 hours after the dose of plerixafor. Participants were to continue to receive G-CSF twice daily and to receive the evening dose of plerixafor followed by apheresis the following morning for a maximum of 4 aphereses or until ≥5*10^6 CD34+ cells/kg were collected.
rituximabBiological
Also called Rituxan, MabThera
Participants were given a weekly dose of rituximab 375mg/m2 by intravenous infusion for 1 week prior to and continuing until 2 weeks after the first dose of G-CSF.
| Study group | Role | What they receive |
|---|---|---|
| G-CSF plus plerixafor | Experimental | Participants with CD20- lymphoma Receives: Drug: G-CSF plus plerixafor |
| G-CSF plus plerixafor and rituximab | Experimental | Participants with CD20+ lymphoma Receives: Drug: G-CSF plus plerixafor; Biological: rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summary of Adverse Events (AEs)
Number of participants with adverse events (AEs) collected from Day 1 (start of G-CSF mobilization in participants with CD20- lymphoma or start of rituximab in participants with CD20+ lymphoma) to the day before starting chemotherapy. AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for seriousness and relatedness to study treatment.
Measured: Day 1 and up to Day 59 (maximum time before start of chemotherapy)
Secondary outcomes (11)
Median Cumulative Number of CD34+ Cells Collected During Apheresis
Median total number of CD34+ cells collected during apheresis.
Measured: Days 5-8
Median Fold Increase in the Number of CD34+ Cells After Plerixafor Administration
Fold Increase = (Pre-Apheresis CD34+ cells/Pre-Plerixafor CD34+ cells).
Measured: Days 4-5
Median Number of Apheresis Days Required to Reach a Minimum of 3*10^6 CD34+ Cells/kg
Median number of apheresis days in each treatment arm to collect a minimum of 3*10^6 CD34+ cells/kg.
Measured: Days 5-8
Median Number of Apheresis Days Required to Reach the Target of 5*10^6 CD34+ Cells/kg
Median number of apheresis days in each treatment arm to reach the target of 5*10^6 CD34+ cells/kg.
Measured: Days 5-8
Median Number of Days to Polymorphonuclear Leukocyte (PMN) Engraftment
Median number of days from transplantation to PMN engraftment which was defined as PMN counts ≥0.5*10^9/L for 3 consecutive days or ≥1.0*10^9/L for 1 day. Time to engraftment corresponded to the first day that the criteria were met.
Measured: Days post transplantation (approximately Day 40)
Median Number of Days to Platelet (PLT) Engraftment
Median number of days from transplantation to PLT engraftment which was defined as platelet counts ≥20*10^9/L without transfusion for the preceding 7 days or platelet counts ≥50*10^9/L for one day. Time to engraftment corresponded to the first day that the criteria were met.
Measured: Days post transplantation (approximately Day 40)
Median Number of Days to Lymphocyte Engraftment
Median number of days from transplantation to lymphocyte engraftment which was defined as lymphocyte counts ≥5*10^8/L. Time to engraftment corresponded to the first day that criteria were met.
Measured: Days post transplantation (approximately Day 40)
Median Level of CD19+CD2-CD14- B-cells Six Months Post-Transplant
Measured: Approximately 7 months (6 months post-transplant)
Median Level of CD19+CD2-CD14- B-cells Twelve Months Post-Transplant
Measured: 13 months (12 months post-transplant)
The Percentage of CD19+CD3-CD14- B-cells of the Total Cells on the First Apheresis Day
Measured: Day 5
Number of Participants With Durable Engraftment 12 Months After Transplantation
The number of participants maintaining a durable graft 12 months after autologous transplantation. A durable graft is defined as the maintenance of normal blood counts.
Measured: Approximately 13 months (12 months post-transplant )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2007 (estimated)
- Study startFeb 2006
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00444912
- Sponsor's protocol ID
- AMD31002113
- Status last verified
- Feb 2014
- First submitted
- 7 Mar 2007
- Last updated
- 13 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Cohort Study of AMD3100 in Combination With G-CSF and Rituximab Compared With AMD3100 in Combination With G-CSF Alone for Mobilization of BPCs in Patients With Relapsed or Refractory NHL or HD Prior to Autologous HPC Transplant
- ClinicalTrials.gov ID
- NCT00444912
- Acronym / sponsor ID
- AMD31002113
- Conditions
- Non-Hodgkin Lymphoma, Hodgkin Disease
- Keywords
- AMD3100, stem cell mobilization, autologous transplant, Non-Hodgkin Lymphoma, Hodgkin Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 8 Mar 2007 (estimated)
- Results
- Posted 29 Jul 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Participants with non-Hodgkin lymphoma (NHL) or Hodgkin disease (HD) will be assigned to one of 2 arms based on the immunophenotype of their lymphoma.
(A)Participants with CD20(-) lymphoma will undergo mobilization with granulocyte colony-stimulating factor (G-CSF) and plerixafor.
(B) Participants with CD20(+) lymphomas will undergo mobilization with rituximab, G-CSF, and plerixafor. They will receive a weekly dose of rituximab beginning 1 week prior to, and continuing until 2 weeks after, the first dose of G-CSF.
Participants in both groups will receive G-CSF twice daily for 4 days. In the evening on Day 4, a dose of plerixafor will be administered. Apheresis will be initiated the next morning. Participants will continue to receive G-CSF twice daily and to receive the evening dose of plerixafor followed by apheresis the next morning for up to a total of 4 aphereses or until ≥5*10^6 CD34+ cells/kg are collected.
Participants who are transplanted will be monitored for the time to polymorphonuclear leukocytes (PMN), platelets (PLT), and lymphocyte engraftment. Follow-up assessments will be done at 100 days, and 6 and 12 months post-transplantation.
Detailed description
This is a single-center, 2-arm, non-randomized, open-label study to evaluate the safety of plerixafor when used in combination with rituximab (Rituxan®) and granulocyte colony-stimulating factor (G-CSF) in patients with relapsed or refractory Hodgkin disease (HD) or non-Hodgkin lymphoma (NHL).
Participants will be assigned to one of 2 arms based on the immunophenotype of their lymphoma.
(A)Participants with CD20(-) lymphoma will undergo mobilization with G-CSF and plerixafor.
(B) Participants with CD20(+) lymphomas will undergo mobilization with rituximab, G-CSF, and plerixafor. They will receive a weekly dose of 375 mg/m2 rituximab by intravenous (iv) infusion beginning 1 week prior to, and continuing until 2 weeks after, the first dose of G-CSF.
Participants in both groups will receive 7.5 µg/kg G-CSF twice daily (morning and evening) for 4 days. In the evening (approximately 10:00 pm) on Day 4, a dose of plerixafor (240 µg/kg) will be administered. Apheresis will be initiated the next morning, approximately 10 to 11 hours after plerixafor is given. Participants will continue to receive G-CSF twice daily and to receive the evening dose of plerixafor followed by apheresis the next morning for up to a total of 4 aphereses or until ≥5*10^6 CD34+ cells/kg are collected.
Participants with an adequate number of autologous peripheral blood stem cells (PBSCs) collected by apheresis will be admitted to the study center for the administration of high-dose chemotherapy and autologous transplantation. After transplantation, the times to PMN, PLT, and lymphocyte engraftment will be measured. Participants will remain hospitalized until they achieve an absolute granulocyte count of >500/µl in the peripheral blood. Graft durability will be assessed at 100 days, and 6 and 12 months post-transplantation.
This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G-CSF plus plerixafor | Experimental | Drug: G-CSF plus plerixaforParticipants with CD20- lymphoma |
| G-CSF plus plerixafor and rituximab | Experimental | Drug: G-CSF plus plerixafor, Biological: rituximabParticipants with CD20+ lymphoma |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histological diagnosis of diffuse large cell lymphoma, B-cell, T-cell or anaplastic histologies; peripheral T-cell lymphoma; small non-cleaved Burkitt-like lymphoma; or Hodgkin disease. NOTE: Participants diagnosed at a facility outside of Emory University will have their diagnosis confirmed by Emory University pathologists prior to being enrolled in this study.
- Eligible for autologous transplantation.
- History of relapse of lymphoma following initial treatment with an anthracycline-containing regimen or disease that is refractory or progresses during initial therapy with an anthracycline-containing regimen.
- Immunophenotyping of the lymphoma at the time of diagnosis or relapse using flow cytometry or immunohistochemistry.
- Presence of clinically- and/or radiologically-documented, measurable, and/or evaluable disease at the time of relapse.
Key exclusion criteria (22 listed)
- A second active malignancy (other than basal cell carcinoma of the skin).
- Uncontrolled central nervous system involvement by lymphoma.
- Positive/history of retroviral infection (HIV, HTLV-1).
- Active infection requiring antibiotics during planned lymphoma-related therapy.
- Previous treatment with high-dose chemotherapy or cytokine mobilization and hematopoietic progenitor cell transplantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| G-CSF plus plerixaforAlso: AMD3100, MozobilParticipants underwent mobilization with G-CSF (7.5 µg/kg twice daily) for 4 days, administered by subcutaneous (sc) injection. On the evening of Day 4, participants received a dose of plerixafor (240 µg/kg), administered by SC injection. On Day 5, participants returned to the clinic and received a morning dose of G-CSF (7.5 µg/kg) and underwent apheresis approximately 10 to 11 hours after the dose of plerixafor. Participants were to continue to receive G-CSF twice daily and to receive the evening dose of plerixafor followed by apheresis the following morning for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected. | Drug | G-CSF plus plerixafor |
| G-CSF plus plerixaforAlso: Mozobil, AMD3100Participants underwent mobilization with G-CSF (7.5 µg/kg twice daily) for 4 days, administered by subcutaneous (SC) injection. On the evening of Day 4, participants received a dose of plerixafor (240 µg/kg), administered by SC injection. On Day 5, participants returned to the clinic and received a morning dose of G-CSF (7.5 µg/kg) and underwent apheresis approximately 10 to 11 hours after the dose of plerixafor. Participants were to continue to receive G-CSF twice daily and to receive the evening dose of plerixafor followed by apheresis the following morning for a maximum of 4 aphereses or until ≥5*10^6 CD34+ cells/kg were collected. | Drug | G-CSF plus plerixafor and rituximab |
| rituximabAlso: Rituxan, MabTheraParticipants were given a weekly dose of rituximab 375mg/m2 by intravenous infusion for 1 week prior to and continuing until 2 weeks after the first dose of G-CSF. | Biological | G-CSF plus plerixafor and rituximab |
Primary outcome
Summary of Adverse Events (AEs)
Time frame: Day 1 and up to Day 59 (maximum time before start of chemotherapy)
Number of participants with adverse events (AEs) collected from Day 1 (start of G-CSF mobilization in participants with CD20- lymphoma or start of rituximab in participants with CD20+ lymphoma) to the day before starting chemotherapy. AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for seriousness and relatedness to study treatment.
11 secondary outcomes
Median Cumulative Number of CD34+ Cells Collected During Apheresis
Time frame: Days 5-8
Median Fold Increase in the Number of CD34+ Cells After Plerixafor Administration
Time frame: Days 4-5
Median Number of Apheresis Days Required to Reach a Minimum of 3*10^6 CD34+ Cells/kg
Time frame: Days 5-8
Median Number of Apheresis Days Required to Reach the Target of 5*10^6 CD34+ Cells/kg
Time frame: Days 5-8
Median Number of Days to Polymorphonuclear Leukocyte (PMN) Engraftment
Time frame: Days post transplantation (approximately Day 40)
Median Number of Days to Platelet (PLT) Engraftment
Time frame: Days post transplantation (approximately Day 40)
Median Number of Days to Lymphocyte Engraftment
Time frame: Days post transplantation (approximately Day 40)
Median Level of CD19+CD2-CD14- B-cells Six Months Post-Transplant
Time frame: Approximately 7 months (6 months post-transplant)
Median Level of CD19+CD2-CD14- B-cells Twelve Months Post-Transplant
Time frame: 13 months (12 months post-transplant)
The Percentage of CD19+CD3-CD14- B-cells of the Total Cells on the First Apheresis Day
Time frame: Day 5
Number of Participants With Durable Engraftment 12 Months After Transplantation
Time frame: Approximately 13 months (12 months post-transplant )
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Genzyme, a Sanofi Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing G-CSF plus plerixafor and rituximab in people with Non-Hodgkin Lymphoma and Hodgkin Disease, run by Genzyme, a Sanofi Company at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Summary of Adverse Events (AEs) (time frame: Day 1 and up to Day 59 (maximum time before start of chemotherapy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2014.